Cannabidiol and Older Adult Cannabis Users (QUARTz)

University of Colorado Boulder (CU)

Status and phase: Enrolling; Phase 2

Conditions: Depression; Anxiety; Pain; Sleep

Treatments: Drug: Placebo; Drug: bsCBD Cannabidiol; Drug: fsCBD Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT06290063

22-08-0138

Details and patient eligibility

About

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Enrollment: 385 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 60 years of age
• Able to provide informed consent
• Must have used a cannabis product at least once with no negative effects
• Must not have been regularly using any cannabis products (<3x/month) in the last 6 months
• Female participants must be postmenopausal
• Liver function tests (Alanine transaminase (ALT) and
• Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age
• Must be currently taking medication/s for pain, sleep, and/or mood

Exclusion criteria

• Blood alcohol level > 0 at screening (to sign consent form)
• Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
• Past or current diagnosis, or family history of diagnosis of psychosis
• Current use of anti-epileptic medications (e.g. clobazam, sodium valproate)
• Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide).
• Current use of antipsychotic medications
• Currently undergoing chemotherapy (to prevent drug interactions)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

385 participants in 3 patient groups, including a placebo group

Full-Spectrum Hemp-Derived CBD (fsCBD)

Experimental group

Description:

8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)

Treatment:

Drug: fsCBD Cannabidiol

Broad-Spectrum Hemp-Derived CBD (bsCBD)

Experimental group

Description:

8 weeks of use of a daily dose of cannabis (200mg CBD)

Treatment:

Drug: bsCBD Cannabidiol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo